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Robert Barnes is half of VivaBarnesLaw, and I am becoming convinced that he is one of the best minds in America today. In fact, I am also coming to the conclusion that he may be the one individual alive who can assume the mantle of the Great Rush Limbaugh. He is extremely smart, knowledgeable, and genial. He can think on his feet without stumbling, and has taken on more than one seemingly hopeless case and won.
A couple of times a week on their Locals channel (VivaBarnesLaw.Locals.com), Robert does an extended Barnes Brief, where he discusses in depth an issue that affects society as a whole. Our Locals community has often asked questions about how the Covid shots were developed, and on Valentine’s Day, this was published. It is long, but quite enlightening, about the process that took place in the development of the shots.
- An argument (I suspect originated from allies of Pfizer) recently emerged in the public discourse that the Covid vaccines are really “bioweapons” which required no clinical testing for safety or efficacy, because Pfizer was merely an agent and instrumentality of the Defense Department. This basically blames Trump for starting a bioweapon program “intended to kill and disable” people under the guise of a vaccine, while also immunizing Pfizer from any suit (including Brook Jackson’s whistleblower claim) as a mere “agent” of the government. To get to this conclusion, various authors misconstrued the procedural manner Operation Warp Speed functioned.
- I see some substack authors pushing a theory that would immunize Pfizer and shift blame to the DOD. These authors often mis-cite the pleadings in the Brook Jackson case I am co-counsel on. They are mistaken. The DOD is definitely in bed with Big Pharma, but legally speaking, Pfizer was not a mere agent of the DOD in this context, and their lies to the government material to Pfizer’s funding. Indeed, the contract required the vaccines not be administered if the FDA ever withheld authorization or withdrew authorization.
- The quickest way to fund an expedited vaccine project was through the Defense Department using its legal authority to develop “prototype” projects. In this case, the prototype was not the vaccine, but the method used to create it – a wide scale, sped-up process of producing medical countermeasures in a pandemic for national security and future military use. The prototype was the process, not the product. This has been misconstrued to make the vaccine a “prototype weapon” because the prototype legislation primarily presumed purchases for weapons, but this confuses the most common use of the law with the purpose of the project here.
- The second, separate item they misconstrued was the legal pleadings in the Brook Jackson case I am co-counsel on. According to these same authors, Pfizer argued they were immune because it was a bioweapon project they were performing as an agent of the government, and the clinical trials were never required to measure for safety or efficacy. According to these same authors, the Government filed paperwork “admitting” to this. This claim is false.
- Pfizer’s DOD contract focused on logistics solely because FDA compliance was a precondition of payment for the contract all the way through. Pfizer tried to play off of this by claiming the absence of all the FDA rules from their DOD contract meant the FDA rules were not preconditions of payment. We rightly satirized Pfizer’s claim as absurd. The reason is the plain language of the contracts Pfizer themselves admitted into the record, contracts these same authors oddly fail to discuss in detail while spinning their seductive Dominion-like conspiracy tale that the Covid vaccines were bioweapons (which, if true, did something they managed to forget to talk about – completely immunize and inoculate Pfizer under sovereign immunity and eviscerate Brook Jackson’s case.)
- In order to procedurally facilitate Operation Warp Speed, the Department of Defense utilized its prototype funding program to accelerate the development of the vaccine. That has been misconstrued to mean the vaccine was a Government “bioweapon”, that clinical trials were neither necessary nor welcome for its production and distribution, and that Pfizer was merely acting as an agent/instrumentality of the federal government. Part of this stems from people accepting Pfizer’s defense at face value that clinical trial regulatory compliance was not a precondition of the award of a $2B DOD contract. This is flatly erroneous. Indeed, the only reason no separate regulation was required by the Defense Department was, as the agreements explicitly and expressly state, because “these clinical trials are regulated by the FDA and HHS.”
- The OTA Base Agreement cited by Pfizer didn’t discard FDA rules, but actually reinstated, reinforced and reincorporated them.
- Section 21.06 of the Base Agreement
- “Deployment and production of medical products and processes fall under the purview of the Food and Drug Administration (FDA) and research on these products involving animal or human studies is regulated by other laws, directives and regulations….Efforts conducted under this OTA shall be done ethically and in accordance with all applicable laws, directives, and regulations.” So much so that Pfizer had to share all FDA information with the DOD, including listening to conferences, sharing all documents , exchanging all communications, allowing government attendance at all visits and audits.
- Section 21.12 of the Base Agreement
- Pfizer had to comply “with current Good Manufacturing Processes as defined by FDA guidance”, including “clinical trials”, and any “failure to comply” that had any “material adverse effect on the safety” of the product would be a “material failure.”
- The Statement of Work (SOW) – the second binding agreement Pfizer admitted and filed into the public record — incorporated the terms of the Base Agreement, as 1.1 of the SOW states the agreement is entered into “pursuant to” it.
- The SOW further stated the agreement is Pfizer’s “provision to the Government, a state of the art candidate vaccine…providing protection against the SARS-Cov-2 threat and related coronaviruses” but only after “subject to technical, clinical and regulatory success.” Pfizer led the government to believe Pfizer could do “unprecedented phase” clinical trial design and its mRna technologies would “abolish the risk of anti-vector immunity.” Indeed, Pfizer promised they could scale fast “while preserving high quality and safety standards.” Pfizer promised its product would be “for the prevention of Covid-19.” The agreement required “regulatory approval” after “conducting clinical trials.” The agreement only provided for funding “if clinical trials are successful and the FDA grants” EUA and BLA licensure.
- Just in case this wasn’t clear enough, the Statement of Work is crystal clear: “Pfizer will meet the necessary FDA requirements for conducting ongoing and planned clinical trials.” Pfizer can only seek FDA approval or authorization if “the clinical data supports such application for approval or authorization.” Indeed, the only reason no separate regulation was required by the Army was because “these clinical trials are regulated by the FDA and HHS.”
- The SOW even goes into detail on the kind of study necessary to “evaluating the safety” of the vaccine — “a randomized, placebo-controlled, observer-blind, dose-finding, and vaccine candidate-selection study in healthy adults.” The SOW describes the clinical trials as “pivotal efficacy study design.” Only upon “adequate safety and efficacy data” could it be approved. The words “FDA approval or authorization” repeat throughout. The SOW even expressly incorporated the EUA preconditions for approval with express EUA process document incorporation. Pfizer’s promise was that “doses shall establish the effectiveness of a technology capable of potentially providing immediate and long-term solutions to coronavirus infections.”
- The SOW repeated throughout that Pfizer must comply “in a manner compliant with applicable laws and regulations” and expressly referenced the Good Manufacturing Practices regulation (21 CFR 210 & 21 CFR 211). The payment was only for “safe and effective doses required for vaccination” and Pfizer was being paid to “deliver those doses” at scale and speed. Any additional production required “particularly favorable” results. Over and over again, the SOW required Pfizer’s drug be a “FDA-approved or authorized vaccine.” Again and again, the DOD required any approval was “subject to FDA-approval or authorization” and “subject to FDA-approval or authorization.” There would be no approval if “clinical” or “regulatory” failure occurred.
- In fact, to further enforce this, Pfizer had to provide the DOD all “data updates from clinical studies.” Additionally, Pfizer had to “notify the Government of any event, risk, formal or informal FDA communication, or other issue” that could impact the project. All payments were “subject to change” based on “clinical trials and the validation of the product.” Just as no payment could be made until successful clinical trials and FDA authorization or approval, the Government could stop payment whenever the FDA withdrew approval or authorization. That is why Pfizer had to provide all the “data updates” from the clinical trials as well as “any and all inspection and compliance notices, observations and responses” of those clinical trials.
- Every great crime needs a great patsy. Pfizer found theirs – the Defense Department. But Pfizer’s still the criminal. Eternal Truth #3.
I suggest that everyone drop by the Locals site, or search for VivaBarnesLaw on Rumble.com, and watch their videos. You will not be disappointed.Published in